International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)

Summary

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (≥50% stenosis) or those without obstructive CAD (\<50% stenosis in all major coronary arteries). Of 8518 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT.

SPECIFIC AIMS

A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT.

B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality; 4) net clinical benefit assessed by including stroke in the primary and secondary composite endpoints; and 5) individual components of the composite endpoints.

Condition: Coronary Disease Procedure: Coronary CT Angiogram Procedure: Cardiac catheterization Phase: Phase III per NIH

Condition: Cardiovascular Diseases Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions Phase: Phase III per NIH

Condition: Heart Diseases Procedure: Coronary Artery Bypass Surgery Phase: Phase III per NIH

Conditions

• Cardiovascular Diseases
• Coronary Disease
• Coronary Artery Disease
• Heart Diseases
• Myocardial Ischemia

Interventions

PROCEDURE

cardiac catheterization

Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.

PROCEDURE

coronary artery bypass graft surgery

Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, "cabbage"). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart.

PROCEDURE

percutaneous coronary intervention

Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.

BEHAVIORAL

Lifestyle

diet, physical activity, smoking cessation

DRUG

Medication

antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies

Sponsors & Collaborators

• New York University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Albany Stratton VA Medical Center

  collaborator FED

• Cedars-Sinai Medical Center

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Duke University

  collaborator OTHER

• East Carolina University

  collaborator OTHER

• Emory University

  collaborator OTHER

• Harvard University

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Montreal Heart Institute

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Missouri, Kansas City

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• NYU Langone Health

  lead OTHER

Principal Investigators

• Judith S Hochman, MD · New York University

• David J Maron, MD · Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2019-06-30

Completion

2023-05-30

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Canada
• China
• Egypt
• France
• Germany
• Hungary
• India
• Israel
• Italy
• Japan
• Lithuania
• Malaysia
• Mexico
• Netherlands
• New Zealand
• North Macedonia
• Peru
• Poland
• Portugal
• Romania
• Russia
• Saudi Arabia
• Serbia
• Singapore
• South Africa
• Spain
• Sweden
• Switzerland
• Taiwan
• Thailand
• United Kingdom

Study Locations